(152 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of examination gloves, with no mention of AI or ML technology.
No
The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to treat or diagnose a disease or condition.
No
Explanation: The device is a "powder free patient examination glove" intended to prevent contamination. It does not perform any diagnostic function.
No
The device description clearly states it is a physical product made of nitrile and chemical additives, intended to be worn on the hand or finger. It is a tangible, disposable glove, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand or finger. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical properties and material of the glove. There is no mention of reagents, calibrators, controls, or any components typically associated with in vitro diagnostic tests.
- Performance Studies: The performance studies described are related to the physical integrity, strength, and biocompatibility of the glove, not the accuracy or reliability of a diagnostic measurement.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
In summary, this device is a medical device intended for barrier protection, not for performing diagnostic tests outside of the body.
N/A
Intended Use / Indications for Use
A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device is for over thecounter use.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
The proposed Disposable Nitrile Examination Gloves are ambidextrous, non-sterile, powder-free, and is made of nitrile (Acrylonitrile-butadiene copolymer) and chemical additives. It has a finger textured surface and is colored blue. This is a single use, disposable device(s), provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner / over-the-counter use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Tests Performed on the Proposed Device
The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Medical Glove Guidance Manual Document, issued on January 22, 2008.
STANDARDS:
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical . Application
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06/(R)2017 Standard Test Method for Residual Powder on Medical Gloves
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices Part 10: Tests For ● Irritation And Skin Sensitization
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices – Part 5: Tests For In Vitro Cytotoxicity
- AAMI / ANSI / ISO 10993-11: 2017 Biological Evaluation Of Medical Devices - Part 11: Tests For Systemic Toxicity
- ISO 10993- 1: 2009/(R)2013 Biological Evaluation of Medical Devices- Part 1: Evaluation and testing within a risk management process
- ISO 10993-2:2006/(R)2014 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
- ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
Key Results:
- Dimensions (ASTM D6319-19): The proposed device meets the specified length, width, and thickness requirements.
- Physical Properties:
- Before Aging: Tensile Strength (MPa) >= 14 min., Ultimate Elongation (%) >= 500 min.
- After Aging: Tensile Strength (MPa) >= 14 min., Ultimate Elongation (%) >= 400 min.
- Freedom from Holes (ASTM D5151): Passes AQL-2.5.
- Residual Power (ASTM D6124): ): No febrile reaction.
- In Vitro Cytotoxicity (ISO 10993-5): MEM test extracts considered cytotoxic potential.
- Intracutaneous Reactivity Test (ISO 10993-10): Polar and non-polar extract score is less than 1.0, meeting requirements.
Conclusion: The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Tensile Strength (MPa) = 14 min.
Ultimate Elongation (%) = 500 min. (before aging), 400 min. (after aging)
AQL 2.5 Inspection Level G-1 for Freedom from Holes
Residual Power (mg/pc) =
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 24, 2021
Shandong DS Safety Technology Co., Ltd. % Rafi Wong Manager Pacific Fortune Management Inc. 2350 Mission College Blvd. Ste 475 Santa Clara, California 95054
Re: K210897
Trade/Device Name: Disposable Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 19, 2021 Received: July 26, 2021
Dear Rafi Wong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Disposable Nitrile Examination Gloves
Indications for Use (Describe)
A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device is for over thecounter use.
| Type of Use (Select one or both, as applicable) |
|---|
| Research involving rCBH subjects only |
| Secondary Research involving rCBH subjects only |
| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510K SUMMARY
Date of Summary Prepared: August 24,2021
510K Number: K210897
1. Submitter Information
Submitter Contact:
| Address: | SHANDONG DS SAFETY TECHNOLOGY CO.,LTD. |
|---|---|
| West of Yaoqian Road, Yaogezhuang Community, | |
| Economic Development Zone, Gaomi City, Weifang City | |
| Shandong 261502, China |
Submitter Contact Person:
| Name: | Summer Feng |
|---|---|
| Phone Number: | +86-0536-2586046 |
| Email: | summer@dsgloves.com |
Designated Submission Correspondent:
| Name: | Rafi Wong |
|---|---|
| Phone Number: | +1 (408) 646-6537 |
| Email: | rafi.wong@pfmfinance.com |
-
- Device Name: Disposable Nitrile Examination Gloves
3. Regulatory Information
| Common Name: | Polymer Patient Examination Glove |
|---|---|
| Apparel Classification: | Class I |
| Product Code: | LZA |
4
Regulation Number: 21 CFR 880.6250
4. Predicate Device
| 510K Number: | K192333 |
|---|---|
| Company name: | JR Engineering & Medical Technologies (M) SDN.BHD. |
| Device Name: | Blue Nitrile Examination Gloves Powder Free |
| Cleared date: | January 24, 2020 |
5. Intended Use
A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device is for over-the-counter use.
6. Device Description
The proposed Disposable Nitrile Examination Gloves are ambidextrous, non-sterile, powder-free, and is made of nitrile (Acrylonitrile-butadiene copolymer) and chemical additives. It has a finger textured surface and is colored blue. This is a single use, disposable device(s), provided non-sterile.
7. Summary of Comparison and Technological Characteristics
| Characteristics | Acceptance
Criteria | Proposed
Device
Disposable
Nitrile
Examination
Gloves | Predicate Device
Blue Nitrile
Examination
Gloves Powder
Free | Comparison |
|-----------------|------------------------|----------------------------------------------------------------------|--------------------------------------------------------------------------|------------|
| 510K Number | / | K210897 | K192333 | - |
| Product Code | LZA | LZA | LZA | Same |
| Manufacturer | / | SHANDONG
DS SAFETY
TECHNOLOGY
CO.,LTD. | JR Engineering &
Medical
Technologies (M)
SDN.BHD. | Different |
Table I - General Comparison
5
| Classification | Class I (21 CFR
880.6250) | Class I (21 CFR
880.6250) | Class I (21 CFR
880.6250) | Same |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Intended Use | A patient
examination glove
is a disposable
device intended for
medical purposes
that is worn on the
examiner's hands or
fingers to prevent
contamination
between patient and
examiner. The
device is for over-
the-counter use. | A powder free
patient
examination
glove is a
disposable
device intended
for medical
purposes that is
worn on the
examiner's hand
or finger to
prevent
contamination
between patient
and examiner.
The device is for
over-the-counter
use. | A powder free
patient
examination
gloves is a
disposable device
intended for
medical purposes
that is worn on the
examiner's hand or
finger to prevent
contamination
between patient
and examiner. | Same |
| Material Use | Nitrile | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Blue | Same |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same |
8. Non-clinical Tests Performed on the Proposed Device
The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Medical Glove Guidance Manual Document, issued on January 22, 2008
STANDARDS:
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical . Application
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06/(R)2017 Standard Test Method for Residual Powder on Medical Gloves
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices Part 10: Tests For ● Irritation And Skin Sensitization
6
- . ISO 10993-5: 2009 Biological Evaluation Of Medical Devices – Part 5: Tests For In Vitro Cytotoxicity
- AAMI / ANSI / ISO 10993-11: 2017 Biological Evaluation Of Medical Devices - Part 11: Tests For Systemic Toxicity
- . ISO 10993- 1: 2009/(R)2013 Biological Evaluation of Medical Devices- Part 1: Evaluation and testing within a risk management process
- . ISO 10993-2:2006/(R)2014 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
- . ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
| | | Proposed
Device | Predicate Device | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------|
| Characteristics | Acceptance
Criteria | Disposable Nitrile
Examination
Gloves
(K210897) | Blue Nitrile
Examination
Gloves Powder
Free (K192333) | Comparison |
| Dimensions
(ASTM D6319-
19) | Overall Length
(mm)
220 mm = (sizes
XS-S)
230 mm = (sizes M-
XL)
Width (± 10 mm)
Size S = 80 mm
Size M = 95 mm
Size L = 110 mm
Size XL = 120 mm
Thickness at Finger
(mm)
All Sizes = 0.05mm
Thickness at Palm
(mm)
All Sizes = 0.05mm | Length (mm)
220 mm = (sizes
XS-S)
230 mm = (sizes
M-XL)
Width (± 10 mm)
Size S = 80 mm
Size M = 95 mm
Size L = 110 mm
Size XL = 120
mm
Thickness-Finger
(mm)
All Sizes≥0.05mm
Thickness-Palm
(mm)
All Sizes≥0.05mm | Size: M
Length Min:
230mm
Palm Width Min:
95+/-10mm
Finger Thickness
min: 0.05 mm
Palm Thickness
min: 0.05 mm | Same |
| Physical
Properties | Tensile Strength
(MPa) = 14 min. | Before Aging ASTM D6319-19
Tensile Strength
(MPa)
14 min | Tensile Strength
(MPa)
14 min. | Same |
Table II - Performance Testing Comparison Table of proposed device K210897 and predicate device K192333
7
| | Ultimate Elongation
(%) = 500 min. | Ultimate
Elongation (%)
500 min. | Ultimate
Elongation (%)
500 min. | Same |
|---------------------------------------|---------------------------------------|--------------------------------------------|--------------------------------------------|------|
| | After Aging ASTM D6319-19 | | | |
| | Tensile Strength
(MPa) = 14 min. | Tensile Strength
(MPa)
$\ge$ 14 min. | Tensile Strength
(MPa)
$\ge$ 14 min. | Same |
| | Ultimate Elongation
(%) = 400 min. | Ultimate
Elongation (%)
400 min. | Ultimate
Elongation (%)
400 min. | Same |
| Freedom from
Holes
(ASTM D5151) | AQL 2.5 Inspection
Level G-1 | Passes AQL-2.5 | Passes AQL-2.5 | Same |
| Residual Power
(ASTM D6124) | $\le$ 2.0 mg/pc | $\le$ 2.0 mg/pc | $\le$ 2.0 mg/pc | Same |
Table III - Biocompatibility Testing Comparison Table
| Characteristics | Acceptance
Criteria | Proposed Device | Predicate
Device | |
|------------------|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------|
| | | Disposable Nitrile
Examination
Gloves | Blue Nitrile
Examination
Gloves Powder
Free | Comparison |
| Biocompatibility | Primary Skin
Irritation Test
ISO 10993-10 | Under the
conditions of the
test, the test article
would be
considered a non-
irritant. | Under the
condition of
study not an
irritant. | Same |
| | Dermal
Sensitization
Assay
ISO 10993-10 | Under the
conditions of this
study, there is no
evidence of skin
sensitization in
guinea pigs was
found. | Under the
conditions of the
study not a
sensitizer. | Same |
| | Acute Systemic
Test
ISO 10993-11 | Under the
conditions of this
study, there is no
mortality or
evidence of
systemic toxicity
from the extracts. | Under the
condition of
study the device
extracts do not
pose a systemic
toxicity concern. | Same |
8
| | The test met the test
requirements. | | |
|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Material
Mediated
Pyrogenicity
ISO 10993-11/
USP 41 | Under the
conditions of this
study, the test
article would be
considered no
febrile reaction. The
test article meets
the test
requirements. | Under the
conditions of the
study, the device
did not
demonstrate a
material
mediated
pyrogenicity
response. | Same |
| In Vitro
Cytotoxicity
ISO 10993-5 | Under the
conditions of this
study, the MEM test
extracts would be
considered
cytotoxic potential. | Under the
conditions of the
study, cytotoxic.
Additional
testing was
performed to
determine if this
was a systemic
toxicity concern. | Same |
| Intracutaneous
Reactivity Test
ISO 10993-10 | The test result
showed that the
polar and non-polar
extract of the final
test sample score is
less 1.0, the
requirements of the
test are met | Not available. | N/A |
9. Clinical Test
There is no clinical study included in this submission.
10. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K210897, the Disposable Nitrile Examination Gloves , is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K192333.